LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk

Launched by HARVARD SCHOOL OF PUBLIC HEALTH (HSPH) · Jan 3, 2025

Keywords

ClinConnect Summary

The LIFT-UP trial is studying whether feeding very low birthweight (VLBW) or very preterm (VPT) infants in the neonatal intensive care unit (NICU) with fortified human milk can help them grow better and become healthier compared to those who receive regular human milk. Fortified human milk means that extra nutrients are added to help these tiny infants gain weight and strength as they grow. The researchers want to find out if this approach leads to better growth by the time the babies leave the hospital and at three months of age, as well as fewer illnesses and lower chances of death.

To be part of this study, infants must be born weighing less than 1.5 kilograms or born before 32 weeks of pregnancy and must be admitted to the NICU shortly after birth. The mothers also need to be alive and available, and they should plan to stay close to the hospital for at least three months. If chosen, participants can expect to follow a specific feeding plan that includes fortified milk. This trial is currently recruiting participants, and it's an important opportunity to potentially improve care for premature and low birthweight infants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Very LBW (≤1.5kg)\* or very preterm (\<32 weeks) infants admitted to NICU at study facility within 24 hours of birth for in-born infants and up to 48 hours for out-born\*\*
• • Mother and infant alive during screening
• • Mother age 18+ years or 16-17 and married (Malawi only)
• • Lives within catchment areas of the facility (50km)
• • Mother intends to stay in catchment area of the study facility for at least 3 months
• • At randomization: Infant receiving at least 60 mL/kg/day of human milk\*\*\*
• Exclusion Criteria:
• • Lives outside the defined catchment area
• • Congenital abnormalities or acquired conditions that interfere with feeding or placement of nasogastric/orogastric tube \[cleft lip/palate, toxoplasmosis, other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, congenital cardiac defect, neural tube defect, gastrointestinal tract anomalies, hydrocephalus, NEC\]
• • Severe birth asphyxia
• • Critically ill (i.e. not on enteral feeds)
• • Unknown date of birth and unknown gestational age